Trial Outcomes & Findings for GPS (Giving Parents Support): Parent Navigation After NICU Discharge (NCT NCT02643472)

Last Updated: 2019-08-05

Results Overview

Parental self-efficacy was measured using the Perceived Maternal Parenting Self-Efficacy Questionnaire (PMPS-E). Mean scores were determined and compared between groups. PMPS-E scores can range from 20-80, and higher scores indicate higher levels of parental self-efficacy.

Recruitment status

COMPLETED

Study phase

Target enrollment

300 participants

Primary outcome timeframe

baseline; 1 week, 1 month, 3 months, 6 months, 12 months after discharge

Results posted on

2019-08-05

Participant Flow

Participant milestones

Participant milestones
Measure	Care Notebook Parents of infants who were discharged from the Children's National NICU will be randomized to receive enhanced usual care by provision of a NICU care resource notebook. Parents will be notified about group assignment prior to discharge. Stratification will occur according to birth weight. Care Notebook: A care notebook will be provided to all parents at discharge. The notebook was created to provide resources and serve as an organizer for appointments for parents of NICU graduates.	Care Notebook + Parent Navigator Parents of infants who were discharged from the Children's National NICU will be randomized to receive a care notebook + Parent Navigation (PN). Parents will be notified about group assignment prior to discharge. Stratification will occur according to the birth weight. Parent Navigator: Parents will be contacted by the parent navigator within 2 business days after discharge to assess how the family is coping, answer questions, and provide necessary resources. Navigators will be in touch with families monthly and according to the parent's needs. The specific PN intervention for each family will be based on each family's needs and therefore may differ. Care Notebook: A care notebook will be provided to all parents at discharge. The notebook was created to provide resources and serve as an organizer for appointments for parents of NICU graduates.
Overall Study STARTED	150	150
Overall Study COMPLETED	123	116
Overall Study NOT COMPLETED	27	34

Reasons for withdrawal

Reasons for withdrawal
Measure	Care Notebook Parents of infants who were discharged from the Children's National NICU will be randomized to receive enhanced usual care by provision of a NICU care resource notebook. Parents will be notified about group assignment prior to discharge. Stratification will occur according to birth weight. Care Notebook: A care notebook will be provided to all parents at discharge. The notebook was created to provide resources and serve as an organizer for appointments for parents of NICU graduates.	Care Notebook + Parent Navigator Parents of infants who were discharged from the Children's National NICU will be randomized to receive a care notebook + Parent Navigation (PN). Parents will be notified about group assignment prior to discharge. Stratification will occur according to the birth weight. Parent Navigator: Parents will be contacted by the parent navigator within 2 business days after discharge to assess how the family is coping, answer questions, and provide necessary resources. Navigators will be in touch with families monthly and according to the parent's needs. The specific PN intervention for each family will be based on each family's needs and therefore may differ. Care Notebook: A care notebook will be provided to all parents at discharge. The notebook was created to provide resources and serve as an organizer for appointments for parents of NICU graduates.
Overall Study Death	2	5
Overall Study Withdrawal by Subject	3	2
Overall Study Protocol Violation	0	1
Overall Study Lost to Follow-up	22	26

Baseline Characteristics

GPS (Giving Parents Support): Parent Navigation After NICU Discharge

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Care Notebook n=150 Participants Parents of infants who were discharged from the Children's National NICU will be randomized to receive enhanced usual care by provision of a NICU care resource notebook. Parents will be notified about group assignment prior to discharge. Stratification will occur according to birth weight. Care Notebook: A care notebook will be provided to all parents at discharge. The notebook was created to provide resources and serve as an organizer for appointments for parents of NICU graduates.	Care Notebook + Parent Navigator n=150 Participants Parents of infants who were discharged from the Children's National NICU will be randomized to receive a care notebook + Parent Navigation. Parents will be notified about group assignment prior to discharge. Stratification will occur according to the birth weight. Parent Navigator: Parents will be contacted by the parent navigator within 2 business days after discharge to assess how the family is coping, answer questions, and provide necessary resources. Navigators will be in touch with families monthly and according to the parent's needs. The specific PN intervention for each family will be based on each family's needs and therefore may differ. Care Notebook: A care notebook will be provided to all parents at discharge. The notebook was created to provide resources and serve as an organizer for appointments for parents of NICU graduates.	Total n=300 Participants Total of all reporting groups
Education College degree or more	70 Participants n=5 Participants	66 Participants n=7 Participants	136 Participants n=5 Participants
Age, Continuous	30.4 years STANDARD_DEVIATION 6.5 • n=5 Participants	29.9 years STANDARD_DEVIATION 6.5 • n=7 Participants	30.1 years STANDARD_DEVIATION 6.5 • n=5 Participants
Sex: Female, Male Female	129 Participants n=5 Participants	138 Participants n=7 Participants	267 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants	12 Participants n=7 Participants	33 Participants n=5 Participants
Race/Ethnicity, Customized Race · American Indian/Pacific Islander	6 Participants n=5 Participants	2 Participants n=7 Participants	8 Participants n=5 Participants
Race/Ethnicity, Customized Race · Asian	11 Participants n=5 Participants	6 Participants n=7 Participants	17 Participants n=5 Participants
Race/Ethnicity, Customized Race · Black	66 Participants n=5 Participants	67 Participants n=7 Participants	133 Participants n=5 Participants
Race/Ethnicity, Customized Race · White	56 Participants n=5 Participants	61 Participants n=7 Participants	117 Participants n=5 Participants
Race/Ethnicity, Customized Race · Mixed race/not reported	11 Participants n=5 Participants	14 Participants n=7 Participants	25 Participants n=5 Participants
Region of Enrollment United States	150 participants n=5 Participants	150 participants n=7 Participants	300 participants n=5 Participants
Education High school or less	34 Participants n=5 Participants	43 Participants n=7 Participants	77 Participants n=5 Participants
Education Trade/vocational/some college	46 Participants n=5 Participants	41 Participants n=7 Participants	87 Participants n=5 Participants
Relationship Single	22 Participants n=5 Participants	27 Participants n=7 Participants	49 Participants n=5 Participants
Relationship Married/partnered	128 Participants n=5 Participants	123 Participants n=7 Participants	251 Participants n=5 Participants
Other children No other children at home	68 Participants n=5 Participants	61 Participants n=7 Participants	129 Participants n=5 Participants
Other children At least one other child	82 Participants n=5 Participants	89 Participants n=7 Participants	171 Participants n=5 Participants
Infant gestational age <32 weeks	39 Participants n=5 Participants	33 Participants n=7 Participants	72 Participants n=5 Participants
Infant gestational age 32-36 weeks	23 Participants n=5 Participants	36 Participants n=7 Participants	59 Participants n=5 Participants
Infant gestational age >=37 weeks	88 Participants n=5 Participants	81 Participants n=7 Participants	169 Participants n=5 Participants
Infant birth weight <1500 grams	32 Participants n=5 Participants	31 Participants n=7 Participants	63 Participants n=5 Participants
Infant birth weight 1500-2499 grams	34 Participants n=5 Participants	29 Participants n=7 Participants	63 Participants n=5 Participants
Infant birth weight >=2500 grams	84 Participants n=5 Participants	90 Participants n=7 Participants	174 Participants n=5 Participants
Infant sex Male	88 Participants n=5 Participants	86 Participants n=7 Participants	174 Participants n=5 Participants
Infant sex Female	62 Participants n=5 Participants	64 Participants n=7 Participants	126 Participants n=5 Participants
Infant length of stay category <=1 week	40 Participants n=5 Participants	38 Participants n=7 Participants	78 Participants n=5 Participants
Infant length of stay category 8-17 days	32 Participants n=5 Participants	41 Participants n=7 Participants	73 Participants n=5 Participants
Infant length of stay category 18-47 days	38 Participants n=5 Participants	37 Participants n=7 Participants	75 Participants n=5 Participants
Infant length of stay category >=48 days	40 Participants n=5 Participants	34 Participants n=7 Participants	74 Participants n=5 Participants

PRIMARY outcome

Timeframe: baseline; 1 week, 1 month, 3 months, 6 months, 12 months after discharge

Outcome measures

Outcome measures
Measure	Care Notebook n=123 Participants Parents of infants who were discharged from the Children's National NICU will be randomized to receive enhanced usual care by provision of a NICU care resource notebook. Parents will be notified about group assignment prior to discharge. Stratification will occur according to birth weight. Care Notebook: A care notebook will be provided to all parents at discharge. The notebook was created to provide resources and serve as an organizer for appointments for parents of NICU graduates. It was based on peer to peer feedback from former NICU parents, in addition, to community resources developed by current Parent Navigator Program at Children's National Health System.	Care Notebook + Parent Navigator n=115 Participants Parents of infants who were discharged from the Children's National NICU will be randomized to receive a care notebook + Parent Navigation. Parents will be notified about group assignment prior to discharge. Stratification will occur according to the birth weight. Parent Navigator: Parents will be contacted by the parent navigator within 2 business days after discharge to assess how the family is coping, answer questions, and provide necessary resources. Navigators will be in touch with families monthly and according to the parent's needs. They will assist the parent in making and keeping appointments, answer questions about insurance coverage, medical equipment and supplies, and serve as a liaison between parent and healthcare providers. However, the specific PN intervention for each family will be based on each family's needs and therefore may differ. Care Notebook: A care notebook will be provided to all parents at discharge. The notebook was created to provide resources and
Parental Self-Efficacy Estimated scores: 1-week	72.7 score on a scale Interval 71.9 to 73.6	72.6 score on a scale Interval 71.7 to 73.5
Parental Self-Efficacy Estimated scores: 6-month	78.0 score on a scale Interval 77.3 to 78.8	77.9 score on a scale Interval 77.1 to 78.7
Parental Self-Efficacy Predicted means: main effect of group	74.94 score on a scale Interval 74.2 to 75.68	74.75 score on a scale Interval 73.96 to 75.55
Parental Self-Efficacy Estimated scores: 1-month	73.8 score on a scale Interval 73.0 to 74.6	73.6 score on a scale Interval 72.8 to 74.5
Parental Self-Efficacy Estimated scores: 3-month	76.0 score on a scale Interval 75.3 to 76.8	75.9 score on a scale Interval 75.1 to 76.7
Parental Self-Efficacy Estimated scores: 12-month	76.9 score on a scale Interval 76.1 to 77.6	76.7 score on a scale Interval 75.9 to 77.6

SECONDARY outcome

Timeframe: baseline; 1 week, 1 month, 3 months, 6 months, 12 months after discharge

Parental anxiety was measured using the State Trait Anxiety Inventory (STAI). Mean scores were determined and compared between groups. The trait portion (Y-2) was only administered at baseline, while the state portion (Y-1) was administered at every interval and used for longitudinal analyses. STAI scores can range from 20-80, and higher scores indicate higher levels of anxiety.

Outcome measures

Outcome measures
Measure	Care Notebook n=123 Participants Parents of infants who were discharged from the Children's National NICU will be randomized to receive enhanced usual care by provision of a NICU care resource notebook. Parents will be notified about group assignment prior to discharge. Stratification will occur according to birth weight. Care Notebook: A care notebook will be provided to all parents at discharge. The notebook was created to provide resources and serve as an organizer for appointments for parents of NICU graduates. It was based on peer to peer feedback from former NICU parents, in addition, to community resources developed by current Parent Navigator Program at Children's National Health System.	Care Notebook + Parent Navigator n=115 Participants Parents of infants who were discharged from the Children's National NICU will be randomized to receive a care notebook + Parent Navigation. Parents will be notified about group assignment prior to discharge. Stratification will occur according to the birth weight. Parent Navigator: Parents will be contacted by the parent navigator within 2 business days after discharge to assess how the family is coping, answer questions, and provide necessary resources. Navigators will be in touch with families monthly and according to the parent's needs. They will assist the parent in making and keeping appointments, answer questions about insurance coverage, medical equipment and supplies, and serve as a liaison between parent and healthcare providers. However, the specific PN intervention for each family will be based on each family's needs and therefore may differ. Care Notebook: A care notebook will be provided to all parents at discharge. The notebook was created to provide resources and
Parental Anxiety Estimated scores: 1-week	31.0 score on a scale Interval 29.6 to 32.3	32.5 score on a scale Interval 31.0 to 34.0
Parental Anxiety Estimated scores: 6-month	27.4 score on a scale Interval 25.9 to 29.0	28.9 score on a scale Interval 27.2 to 30.7
Parental Anxiety Predicted means: main effect of group	29.55 score on a scale Interval 28.24 to 30.87	31.14 score on a scale Interval 29.68 to 32.61
Parental Anxiety Estimated scores: 1-month	30.2 score on a scale Interval 28.9 to 31.6	31.8 score on a scale Interval 30.3 to 33.2
Parental Anxiety Estimated scores: 3-month	28.7 score on a scale Interval 27.3 to 30.1	30.2 score on a scale Interval 28.6 to 31.8
Parental Anxiety Estimated scores: 12-month	28.7 score on a scale Interval 27.0 to 30.4	30.2 score on a scale Interval 28.5 to 32.0

SECONDARY outcome

Timeframe: baseline; 1 week, 1 month, 3 months, 6 months, 12 months after discharge

Parental stress was measured using the Parental Stress Scale (PSS). Mean scores were determined and compared between groups. PSS scores can range from 18-90, and higher scores indicate higher levels of parental stress.

Outcome measures

Outcome measures
Measure	Care Notebook n=123 Participants Parents of infants who were discharged from the Children's National NICU will be randomized to receive enhanced usual care by provision of a NICU care resource notebook. Parents will be notified about group assignment prior to discharge. Stratification will occur according to birth weight. Care Notebook: A care notebook will be provided to all parents at discharge. The notebook was created to provide resources and serve as an organizer for appointments for parents of NICU graduates. It was based on peer to peer feedback from former NICU parents, in addition, to community resources developed by current Parent Navigator Program at Children's National Health System.	Care Notebook + Parent Navigator n=115 Participants Parents of infants who were discharged from the Children's National NICU will be randomized to receive a care notebook + Parent Navigation. Parents will be notified about group assignment prior to discharge. Stratification will occur according to the birth weight. Parent Navigator: Parents will be contacted by the parent navigator within 2 business days after discharge to assess how the family is coping, answer questions, and provide necessary resources. Navigators will be in touch with families monthly and according to the parent's needs. They will assist the parent in making and keeping appointments, answer questions about insurance coverage, medical equipment and supplies, and serve as a liaison between parent and healthcare providers. However, the specific PN intervention for each family will be based on each family's needs and therefore may differ. Care Notebook: A care notebook will be provided to all parents at discharge. The notebook was created to provide resources and
Parental Stress Predicted means: main effect of group	27.47 score on a scale Interval 26.34 to 28.6	29.29 score on a scale Interval 28.16 to 30.42
Parental Stress Estimated scores: 6-month	25.7 score on a scale Interval 24.5 to 27.0	27.5 score on a scale Interval 26.3 to 28.8
Parental Stress Estimated scores: 1-week	28.6 score on a scale Interval 27.4 to 29.7	30.4 score on a scale Interval 29.2 to 31.5
Parental Stress Estimated scores: 1-month	28.0 score on a scale Interval 26.8 to 29.1	29.8 score on a scale Interval 28.6 to 30.9
Parental Stress Estimated scores: 3-month	26.7 score on a scale Interval 25.5 to 27.9	28.5 score on a scale Interval 27.3 to 29.7
Parental Stress Estimated scores: 12-month	27.1 score on a scale Interval 25.8 to 28.4	28.9 score on a scale Interval 27.5 to 30.2

SECONDARY outcome

Timeframe: baseline, 1 week, 1 mo, 3 mo, 6 mo, 12 months after discharge

General stress was measured using the Perceived Stress Scale (PSS-10), a 10-item instrument which asks respondents to consider their feelings and thoughts during the last month. Total scores range from 0-40, with higher scores indicating higher levels of stress

Outcome measures

Outcome measures
Measure	Care Notebook n=123 Participants Parents of infants who were discharged from the Children's National NICU will be randomized to receive enhanced usual care by provision of a NICU care resource notebook. Parents will be notified about group assignment prior to discharge. Stratification will occur according to birth weight. Care Notebook: A care notebook will be provided to all parents at discharge. The notebook was created to provide resources and serve as an organizer for appointments for parents of NICU graduates. It was based on peer to peer feedback from former NICU parents, in addition, to community resources developed by current Parent Navigator Program at Children's National Health System.	Care Notebook + Parent Navigator n=115 Participants Parents of infants who were discharged from the Children's National NICU will be randomized to receive a care notebook + Parent Navigation. Parents will be notified about group assignment prior to discharge. Stratification will occur according to the birth weight. Parent Navigator: Parents will be contacted by the parent navigator within 2 business days after discharge to assess how the family is coping, answer questions, and provide necessary resources. Navigators will be in touch with families monthly and according to the parent's needs. They will assist the parent in making and keeping appointments, answer questions about insurance coverage, medical equipment and supplies, and serve as a liaison between parent and healthcare providers. However, the specific PN intervention for each family will be based on each family's needs and therefore may differ. Care Notebook: A care notebook will be provided to all parents at discharge. The notebook was created to provide resources and
General Stress Estimated scores: 1-month	13.3 score on a scale Interval 12.4 to 14.3	14.5 score on a scale Interval 13.5 to 15.4
General Stress Estimated scores: 3-month	11.2 score on a scale Interval 10.2 to 12.3	12.4 score on a scale Interval 11.3 to 13.4
General Stress Estimated scores: 6-month	9.6 score on a scale Interval 8.5 to 10.8	10.8 score on a scale Interval 9.6 to 11.9
General Stress Estimated scores: 12-month	11.9 score on a scale Interval 10.7 to 13.1	13.0 score on a scale Interval 11.8 to 14.2
General Stress Predicted means: main effect of group	12.51 score on a scale Interval 11.56 to 13.46	13.74 score on a scale Interval 12.78 to 14.7
General Stress Estimated scores: 1-week	14.3 score on a scale Interval 13.3 to 15.3	15.5 score on a scale Interval 14.5 to 16.4

SECONDARY outcome

Timeframe: Baseline

The Parental Stressor Scale:Neonatal Intensive Care Unit (PSS:NICU) was used to measure NICU-specific stress. Mean total and subscale scores were determined using Metric 1 (applicable stress) and compared between groups. PSS:NICU scores can range from 1-5, and higher scores indicate higher levels of NICU-specific stress.

Outcome measures

Outcome measures
Measure	Care Notebook n=148 Participants Parents of infants who were discharged from the Children's National NICU will be randomized to receive enhanced usual care by provision of a NICU care resource notebook. Parents will be notified about group assignment prior to discharge. Stratification will occur according to birth weight. Care Notebook: A care notebook will be provided to all parents at discharge. The notebook was created to provide resources and serve as an organizer for appointments for parents of NICU graduates. It was based on peer to peer feedback from former NICU parents, in addition, to community resources developed by current Parent Navigator Program at Children's National Health System.	Care Notebook + Parent Navigator n=148 Participants Parents of infants who were discharged from the Children's National NICU will be randomized to receive a care notebook + Parent Navigation. Parents will be notified about group assignment prior to discharge. Stratification will occur according to the birth weight. Parent Navigator: Parents will be contacted by the parent navigator within 2 business days after discharge to assess how the family is coping, answer questions, and provide necessary resources. Navigators will be in touch with families monthly and according to the parent's needs. They will assist the parent in making and keeping appointments, answer questions about insurance coverage, medical equipment and supplies, and serve as a liaison between parent and healthcare providers. However, the specific PN intervention for each family will be based on each family's needs and therefore may differ. Care Notebook: A care notebook will be provided to all parents at discharge. The notebook was created to provide resources and
Parental Stress in the Neonatal Intensive Care Unit	2.11 score on a scale Standard Deviation 0.92	1.99 score on a scale Standard Deviation 0.80

SECONDARY outcome

Timeframe: baseline; 1 month, 3 months, 6 months, 12 months after discharge

Parental depression was measured using the 10-item Center for Epidemiological Study Depression Scale (CES-D 10). Mean scores were determined and compared between groups. CES-D 10 scores can range from 0-30, and a score \>=10 indicates the presence of depressive symptoms.

Outcome measures

Outcome measures
Measure	Care Notebook n=123 Participants Parents of infants who were discharged from the Children's National NICU will be randomized to receive enhanced usual care by provision of a NICU care resource notebook. Parents will be notified about group assignment prior to discharge. Stratification will occur according to birth weight. Care Notebook: A care notebook will be provided to all parents at discharge. The notebook was created to provide resources and serve as an organizer for appointments for parents of NICU graduates. It was based on peer to peer feedback from former NICU parents, in addition, to community resources developed by current Parent Navigator Program at Children's National Health System.	Care Notebook + Parent Navigator n=116 Participants Parents of infants who were discharged from the Children's National NICU will be randomized to receive a care notebook + Parent Navigation. Parents will be notified about group assignment prior to discharge. Stratification will occur according to the birth weight. Parent Navigator: Parents will be contacted by the parent navigator within 2 business days after discharge to assess how the family is coping, answer questions, and provide necessary resources. Navigators will be in touch with families monthly and according to the parent's needs. They will assist the parent in making and keeping appointments, answer questions about insurance coverage, medical equipment and supplies, and serve as a liaison between parent and healthcare providers. However, the specific PN intervention for each family will be based on each family's needs and therefore may differ. Care Notebook: A care notebook will be provided to all parents at discharge. The notebook was created to provide resources and
Parental Depression Estimated scores: 6-month	4.0 score on a scale Interval 3.3 to 4.8	5.0 score on a scale Interval 4.1 to 5.8
Parental Depression Estimated scores: 12-month	6.2 score on a scale Interval 5.3 to 7.1	7.1 score on a scale Interval 6.2 to 8.0
Parental Depression Predicted means: main effect of group	6.04 score on a scale Interval 5.34 to 6.73	6.98 score on a scale Interval 6.29 to 7.68
Parental Depression Estimated scores: 1-month	6.9 score on a scale Interval 6.2 to 7.6	7.8 score on a scale Interval 7.1 to 8.5
Parental Depression Estimated scores: 3-month	5.3 score on a scale Interval 4.6 to 6.0	6.2 score on a scale Interval 5.4 to 6.9

SECONDARY outcome

Timeframe: One year

Infant ED visits were parent-reported and totaled over a period of 12 months.

Outcome measures

Outcome measures
Measure	Care Notebook n=147 Participants Parents of infants who were discharged from the Children's National NICU will be randomized to receive enhanced usual care by provision of a NICU care resource notebook. Parents will be notified about group assignment prior to discharge. Stratification will occur according to birth weight. Care Notebook: A care notebook will be provided to all parents at discharge. The notebook was created to provide resources and serve as an organizer for appointments for parents of NICU graduates. It was based on peer to peer feedback from former NICU parents, in addition, to community resources developed by current Parent Navigator Program at Children's National Health System.	Care Notebook + Parent Navigator n=145 Participants Parents of infants who were discharged from the Children's National NICU will be randomized to receive a care notebook + Parent Navigation. Parents will be notified about group assignment prior to discharge. Stratification will occur according to the birth weight. Parent Navigator: Parents will be contacted by the parent navigator within 2 business days after discharge to assess how the family is coping, answer questions, and provide necessary resources. Navigators will be in touch with families monthly and according to the parent's needs. They will assist the parent in making and keeping appointments, answer questions about insurance coverage, medical equipment and supplies, and serve as a liaison between parent and healthcare providers. However, the specific PN intervention for each family will be based on each family's needs and therefore may differ. Care Notebook: A care notebook will be provided to all parents at discharge. The notebook was created to provide resources and
ED Visits	0 ED visits Interval 0.0 to 1.0	0 ED visits Interval 0.0 to 1.0

SECONDARY outcome

Timeframe: One year

Infant hospitalizations were parent-reported and totaled over a period of 12 months.

Outcome measures

Outcome measures
Measure	Care Notebook n=147 Participants Parents of infants who were discharged from the Children's National NICU will be randomized to receive enhanced usual care by provision of a NICU care resource notebook. Parents will be notified about group assignment prior to discharge. Stratification will occur according to birth weight. Care Notebook: A care notebook will be provided to all parents at discharge. The notebook was created to provide resources and serve as an organizer for appointments for parents of NICU graduates. It was based on peer to peer feedback from former NICU parents, in addition, to community resources developed by current Parent Navigator Program at Children's National Health System.	Care Notebook + Parent Navigator n=145 Participants Parents of infants who were discharged from the Children's National NICU will be randomized to receive a care notebook + Parent Navigation. Parents will be notified about group assignment prior to discharge. Stratification will occur according to the birth weight. Parent Navigator: Parents will be contacted by the parent navigator within 2 business days after discharge to assess how the family is coping, answer questions, and provide necessary resources. Navigators will be in touch with families monthly and according to the parent's needs. They will assist the parent in making and keeping appointments, answer questions about insurance coverage, medical equipment and supplies, and serve as a liaison between parent and healthcare providers. However, the specific PN intervention for each family will be based on each family's needs and therefore may differ. Care Notebook: A care notebook will be provided to all parents at discharge. The notebook was created to provide resources and
Hospitalizations	0 Hospitalizations Interval 0.0 to 0.0	0 Hospitalizations Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: One year

Infant immunization status was either provider-reported or accessed via a state registry. The number of neonates with a complete immunization series within 12 months after discharge were compared between groups. Complete immunization status was defined as receipt of 3 diphtheria tetanus acellular pertussis (DTaP) vaccines, 3 pneumococcal conjugate vaccines (PCV13), and either 2 or 3 Hemophilus influenzae b (HIB) vaccines, depending on vaccine type (e.g. PedvaxHIB at 2 and 4 months, ActHIB at 2, 4, and 6 months).

Outcome measures

Outcome measures
Measure	Care Notebook n=143 Participants Parents of infants who were discharged from the Children's National NICU will be randomized to receive enhanced usual care by provision of a NICU care resource notebook. Parents will be notified about group assignment prior to discharge. Stratification will occur according to birth weight. Care Notebook: A care notebook will be provided to all parents at discharge. The notebook was created to provide resources and serve as an organizer for appointments for parents of NICU graduates. It was based on peer to peer feedback from former NICU parents, in addition, to community resources developed by current Parent Navigator Program at Children's National Health System.	Care Notebook + Parent Navigator n=136 Participants Parents of infants who were discharged from the Children's National NICU will be randomized to receive a care notebook + Parent Navigation. Parents will be notified about group assignment prior to discharge. Stratification will occur according to the birth weight. Parent Navigator: Parents will be contacted by the parent navigator within 2 business days after discharge to assess how the family is coping, answer questions, and provide necessary resources. Navigators will be in touch with families monthly and according to the parent's needs. They will assist the parent in making and keeping appointments, answer questions about insurance coverage, medical equipment and supplies, and serve as a liaison between parent and healthcare providers. However, the specific PN intervention for each family will be based on each family's needs and therefore may differ. Care Notebook: A care notebook will be provided to all parents at discharge. The notebook was created to provide resources and
Infant Immunization Status Fully immunized	107 Participants	98 Participants
Infant Immunization Status Not fully immunized	36 Participants	38 Participants

SECONDARY outcome

Timeframe: One year

Infant developmental status was measured using the Bayley Scales of Infant and Toddler Development, Third Edition (Bayley III). The Bayley III was administered between 11-13 months of study follow-up, and it used corrected infant age to account for prematurity. Composite scores for cognitive, language, and motor domains were determined and compared between groups. Bayley scores can range from 40-160, and higher scores indicate higher levels of infant development.

Outcome measures

Outcome measures
Measure	Care Notebook n=65 Participants Parents of infants who were discharged from the Children's National NICU will be randomized to receive enhanced usual care by provision of a NICU care resource notebook. Parents will be notified about group assignment prior to discharge. Stratification will occur according to birth weight. Care Notebook: A care notebook will be provided to all parents at discharge. The notebook was created to provide resources and serve as an organizer for appointments for parents of NICU graduates. It was based on peer to peer feedback from former NICU parents, in addition, to community resources developed by current Parent Navigator Program at Children's National Health System.	Care Notebook + Parent Navigator n=62 Participants Parents of infants who were discharged from the Children's National NICU will be randomized to receive a care notebook + Parent Navigation. Parents will be notified about group assignment prior to discharge. Stratification will occur according to the birth weight. Parent Navigator: Parents will be contacted by the parent navigator within 2 business days after discharge to assess how the family is coping, answer questions, and provide necessary resources. Navigators will be in touch with families monthly and according to the parent's needs. They will assist the parent in making and keeping appointments, answer questions about insurance coverage, medical equipment and supplies, and serve as a liaison between parent and healthcare providers. However, the specific PN intervention for each family will be based on each family's needs and therefore may differ. Care Notebook: A care notebook will be provided to all parents at discharge. The notebook was created to provide resources and
Infant Developmental Status Language	88.49 score on a scale Standard Deviation 15.33	86.89 score on a scale Standard Deviation 17.49
Infant Developmental Status Cognitive	97.83 score on a scale Standard Deviation 16.25	98.13 score on a scale Standard Deviation 17.13
Infant Developmental Status Motor	91.26 score on a scale Standard Deviation 16.02	91.79 score on a scale Standard Deviation 18.98

Adverse Events

Care Notebook

Serious events: 0 serious events

Other events: 0 other events

Deaths: 2 deaths

Care Notebook + Parent Navigator

Serious events: 0 serious events

Other events: 0 other events

Deaths: 5 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Karen Fratantoni

Children's National Health System

Phone: 202-476-4793

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place