Trial Outcomes & Findings for Delayed Cord Clamping for Congenital Diaphragmatic Hernia (NCT NCT03314233)

Results Overview

Infants who are intubated and have ventilation initiated prior to umbilical cord clamping

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

21 participants

Primary outcome timeframe

3 minutes of life

Results posted on

2020-01-21

Participant Flow

Participant milestones

Participant milestones
Measure	DING Intervention Delayed Cord Clamping DING: Immediately after birth, the infant will be placed on a Lifestart trolley with an intact umbilical cord, intubated, and ventilated with the Children's Hospital of Philadelphia (CHOP) "gentle ventilation" protocol.
Overall Study STARTED	21
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	DING Intervention Delayed Cord Clamping DING: Immediately after birth, the infant will be placed on a Lifestart trolley with an intact umbilical cord, intubated, and ventilated with the Children's Hospital of Philadelphia (CHOP) "gentle ventilation" protocol.
Overall Study No longer eligible at time of delivery	1

Baseline Characteristics

Delayed Cord Clamping for Congenital Diaphragmatic Hernia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	DING Intervention n=20 Participants Delayed Cord Clamping DING: Immediately after birth, the infant will be placed on a Lifestart trolley with an intact umbilical cord, intubated, and ventilated with the Children's Hospital of Philadelphia (CHOP) "gentle ventilation" protocol.
Age, Customized Gestational Age	38.7 weeks STANDARD_DEVIATION 0.5 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	17 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3 minutes of life

Infants who are intubated and have ventilation initiated prior to umbilical cord clamping

Outcome measures

Outcome measures
Measure	DING Intervention n=20 Participants Delayed Cord Clamping DING: Immediately after birth, the infant will be placed on a Lifestart trolley with an intact umbilical cord, intubated, and ventilated with the Children's Hospital of Philadelphia (CHOP) "gentle ventilation" protocol.
Proportion of Infants Who Are Intubated Prior to Umbilical Cord Clamping	17 Participants

SECONDARY outcome

Timeframe: Approximately 1 hour of life

Population: 1 of the 20 infants randomized to the intervention was diagnosis with a second major anomaly postnatally and was not included in the secondary outcome results.

Arterial pH on first blood gas

Outcome measures

Outcome measures
Measure	DING Intervention n=19 Participants Delayed Cord Clamping DING: Immediately after birth, the infant will be placed on a Lifestart trolley with an intact umbilical cord, intubated, and ventilated with the Children's Hospital of Philadelphia (CHOP) "gentle ventilation" protocol.
Mean Arterial Potential of Hydrogen (pH) in Arterial Blood	7.02 pH Standard Deviation 0.15

SECONDARY outcome

Timeframe: Approximately 1 hour of life

Population: 1 of the 20 infants randomized to the intervention was diagnosis with a second major anomaly postnatally and was not included in the secondary outcome results.

Arterial PaO2 on first blood gas

Outcome measures

Outcome measures
Measure	DING Intervention n=19 Participants Delayed Cord Clamping DING: Immediately after birth, the infant will be placed on a Lifestart trolley with an intact umbilical cord, intubated, and ventilated with the Children's Hospital of Philadelphia (CHOP) "gentle ventilation" protocol.
Mean Partial Pressure of O2 in Arterial Blood (PaO2)	47 PaO2 Interval 39.0 to 52.0

SECONDARY outcome

Timeframe: First obtained blood gas

Population: 1 of the 20 infants randomized to the intervention was diagnosis with a second major anomaly postnatally and was not included in the secondary outcome results.

Oxygenation index \[OI\] with first obtained blood gas

Outcome measures

Outcome measures
Measure	DING Intervention n=19 Participants Delayed Cord Clamping DING: Immediately after birth, the infant will be placed on a Lifestart trolley with an intact umbilical cord, intubated, and ventilated with the Children's Hospital of Philadelphia (CHOP) "gentle ventilation" protocol.
Oxygenation Index (OI)	17.5 oxygenation index Interval 12.8 to 25.5

SECONDARY outcome

Timeframe: First 48 hours of life

Population: 1 of the 20 infants randomized to the intervention was diagnosis with a second major anomaly postnatally and was not included in the secondary outcome results.

Proportion of infants who require vasopressors in first 48 hours of life

Outcome measures

Outcome measures
Measure	DING Intervention n=19 Participants Delayed Cord Clamping DING: Immediately after birth, the infant will be placed on a Lifestart trolley with an intact umbilical cord, intubated, and ventilated with the Children's Hospital of Philadelphia (CHOP) "gentle ventilation" protocol.
Proportion of Infants Who Require Vasopressors	13 Participants

SECONDARY outcome

Timeframe: Approximately 24 hours of life

Population: 1 of the 20 infants randomized to the intervention was diagnosis with a second major anomaly postnatally and was not included in the secondary outcome results. 1 trial participant was supported with ECMO when the echocardiogram was obtained and therefore was not assessed.

Presence of severe pulmonary hypertension on first echocardiogram

Outcome measures

Outcome measures
Measure	DING Intervention n=18 Participants Delayed Cord Clamping DING: Immediately after birth, the infant will be placed on a Lifestart trolley with an intact umbilical cord, intubated, and ventilated with the Children's Hospital of Philadelphia (CHOP) "gentle ventilation" protocol.
Presence of Severe Pulmonary Hypertension	12 Participants

SECONDARY outcome

Timeframe: 7 days of life

Population: 1 of the 20 infants randomized to the intervention was diagnosis with a second major anomaly postnatally and was not included in the secondary outcome results.

Proportion of infants who require ECMO treatment in first 7 days of life

Outcome measures

Outcome measures
Measure	DING Intervention n=19 Participants Delayed Cord Clamping DING: Immediately after birth, the infant will be placed on a Lifestart trolley with an intact umbilical cord, intubated, and ventilated with the Children's Hospital of Philadelphia (CHOP) "gentle ventilation" protocol.
Proportion of Infants Who Require Extracorporeal Membrane Oxygenation (ECMO) Treatment	7 Participants

SECONDARY outcome

Timeframe: First 7 days of life

Proportion of infants with mortality in the first 7 days of life

Outcome measures

Outcome measures
Measure	DING Intervention n=20 Participants Delayed Cord Clamping DING: Immediately after birth, the infant will be placed on a Lifestart trolley with an intact umbilical cord, intubated, and ventilated with the Children's Hospital of Philadelphia (CHOP) "gentle ventilation" protocol.
Mortality in First 7 Days of Life	0 Participants

Adverse Events

DING Intervention

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	DING Intervention n=20 participants at risk Delayed Cord Clamping DING: Immediately after birth, the infant will be placed on a Lifestart trolley with an intact umbilical cord, intubated, and ventilated with the Children's Hospital of Philadelphia (CHOP) "gentle ventilation" protocol.
Respiratory, thoracic and mediastinal disorders Pneumothorax	15.0% 3/20 • 24 hours following allocation to the DING intervention.

Other adverse events

Adverse event data not reported

Additional Information

Dr. Elizabeth Foglia

Childrens Hospital of Philadelphia

Phone: 215-590-1653

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place