Trial Outcomes & Findings for An Intervention to Decrease Infant Crying (NCT NCT00796523)

NCT ID: NCT00796523

Last Updated: 2008-11-24

Results Overview

total hours per day of fuss, cry, and unsoothable crying.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 51 participants
• Primary outcome timeframe: week 8
• Results posted on: 2008-11-24

Participant Flow

Mothers of healthy singleton newborn infants with a gestational age of 37-41 weeks admitted to the normal newborn nursery of a large community hospital were given a flier inviting them to participate by contacting the research assistant by phone.

1408 Fliers were distributed and 51 mothers contacted the research assistant for enrollment in the study.

Participant milestones

Measure	Happiest Baby Videotape videotape describing the Happiest Baby on the Block technique	Control Videotape videotape with normal newborn instruction
Overall Study STARTED	27	24
Overall Study COMPLETED	18	17
Overall Study NOT COMPLETED	9	7

Reasons for withdrawal

Measure	Happiest Baby Videotape videotape describing the Happiest Baby on the Block technique	Control Videotape videotape with normal newborn instruction
Overall Study Lost to Follow-up	9	7

Baseline Characteristics

An Intervention to Decrease Infant Crying

Baseline characteristics by cohort

Measure	Happiest Baby Videotape n=27 Participants videotape describing the Happiest Baby on the Block technique	Control Videotape n=24 Participants videotape with normal newborn instruction	Total n=51 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	27 Participants n=5 Participants	24 Participants n=7 Participants	51 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	3 days STANDARD_DEVIATION 1 • n=5 Participants	3 days STANDARD_DEVIATION 1 • n=7 Participants	3 days STANDARD_DEVIATION 1 • n=5 Participants
Age, Customized <=5 days	27 participants n=5 Participants	24 participants n=7 Participants	51 participants n=5 Participants
Age, Customized >5 days	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants
Sex: Female, Male Female	27 Participants n=5 Participants	24 Participants n=7 Participants	51 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	27 participants n=5 Participants	24 participants n=7 Participants	51 participants n=5 Participants

PRIMARY outcome

Timeframe: week 8

Population: If fewer than 3 diaries were completed for a given time period (that is, one or two of the days was missing or had more than 180 minutes unrecorded), then the average of only the completed diaries was used. Results are based on ITT; 16 subjects did not complete any diaries and are not included in the analysis

total hours per day of fuss, cry, and unsoothable crying.

Outcome measures

Measure	Happiest Baby Videotape n=18 Participants videotape describing the Happiest Baby on the Block technique	Control Videotape n=17 Participants videotape with normal newborn instruction
Hours Per Day of Fuss/Cry	2.20 hours per day Standard Deviation 1.25	1.48 hours per day Standard Deviation 1.23

PRIMARY outcome

Timeframe: week 8

Population: Results based on ITT; 16 subjects did not complete any diaries and are not included in the analysis

mean sleep time is the mean of 3 daily sleep times reported in a time period.

Outcome measures

Measure	Happiest Baby Videotape n=18 Participants videotape describing the Happiest Baby on the Block technique	Control Videotape n=17 Participants videotape with normal newborn instruction
Hours Per Day of Sleep	13.87 hours per day Standard Deviation 1.60	14.1 hours per day Standard Deviation 1.73

SECONDARY outcome

Timeframe: week 6

Population: results based on ITT; 16 subjects did not complete any diaries or data collection instruments and are not included in the analysis

a continuous scale measuring stress with a range of 131 (low) to 320 (high); the average person's stress scores are between 188 and 252.

Outcome measures

Measure	Happiest Baby Videotape n=18 Participants videotape describing the Happiest Baby on the Block technique	Control Videotape n=17 Participants videotape with normal newborn instruction
Parenting Stress Index	225.3 points on a scale Standard Deviation 35.3	188.9 points on a scale Standard Deviation 27.9

Adverse Events

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jonna M. McRury, M.D.

University of Toledo

Phone: 419-389-1118

Email: jmcrury@aol.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place