Trial · NCT01702805

Transfusion of Prematures Trial

NCT01702805, Not applicable, Completed, NICHD Neonatal Research Network; results first posted 2022-02-11

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Transfusion of Prematures Trial. Trials, record NCT01702805. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01702805

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Transfusion of Prematures Trial
NCT number: NCT01702805
Status: Completed
Phases: Not applicable
Enrollment: 1,824 participants, actual
Lead sponsor: NICHD Neonatal Research Network
Conditions: Infant, Newborn, Diseases, Infant, Extremely Low Birth Weight, Infant, Small for Gestational Age, Bronchopulmonary Dysplasia (BPD), Anemia
Interventions: Liberal Cell Transfusion, Restricted red cell transfusion
First posted: 2012-10-08
Last updated: 2025-11-14
Results first posted: 2022-02-11

Source ClinicalTrials.gov

Registered outcomes30

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Death or Neurodevelopmental Impairment	Birth to 22-26 months corrected age	A composite outcome that measures the occurrence of death or neurodevelomental impairment between birth and 22-26 months corrected age.
Primary	Death	Birth to 22-26 months corrected age	This is measured as Yes if an infant died between birth and 22-26 months corrected age; Otherwise, No.
Primary	Neurodevelopmental Impairment	at 22-26 months corrected age	This is measured as Yes if any hearing impairment or visual impairment is noted, if severe or moderate cerebral palsy is noted, or if the cognitive score of the Bayley III score is more than 1 standard deviation below the average; Otherwise, No.
Primary	Cognitive Delay	at 22-26 months corrected age	This is measured as Yes if the Bayley Scale of Infant and Toddler Development (BSID)-III cognitive score is more than 1 standard deviation below the average; Otherwise, No.
Primary	Moderate or Severe Cerebral Palsy	at 22-26 months corrected age	This is measured as Yes if the Gross Motor Function Classification System (GMFCS) score is level II or higher; Otherwise, No. Higher values of the GMFCS are worse than lower values; a level of "I" denotes mild cerebral palsy (CP); level "II" or "III" moderate CP; level "IV" or "V" severe CP.
Primary	Severe Vision Impairment	at 22-26 months corrected age	This is measured as Yes if the corrected visual acuity in the better eye of less than 20/200; Otherwise, No.
Primary	Severe Hearing Impairment	at 22-26 months corrected age	This is measured as Yes if bilateral hearing loss occurred for which hearing aids or cochlear implants were warranted; Otherwise, No.
Secondary	Survival to Discharge Without Severe Complications	Birth to initial hospital discharge or to death if it occurs earlier (a median of 97 days)	This is measured as Yes if survived to discharge without severe morbidity, defined as bronchopulmonary dysplasia, retinopathy of prematurity (stage 3 or higher or requiring treatment), or serious brain abnormality; Otherwise, No.
Secondary	Bronchopulmonary Dysplasia, Diagnosed on the Basis of the Need for Supplemental Oxygen After a Standardized Oxygen Reduction Test at 36 Weeks of Postmenstrual Age	at 36 weeks postmenstrual age	This is measured as Yes if experienced bronchopulmonary dysplasia, diagnosed on the basis of the need for supplemental oxygen after a standardized oxygen reduction test at 36 weeks of postmenstrual age; Otherwise, No.
Secondary	Retinopathy of Prematurity Stage >=3 or Treatment for That Condition Received	Birth to initial hospital discharge or to death if it occurs earlier (a median of 97 days)	This is measured as Yes if experienced Retinopathy of Prematurity (ROP) Stage \>=3 or received treatment for that condition; Otherwise, No. Higher stages of ROP indicate a worse outcome; the stages range from 1 for "mild" disease, to 5 for "severe" disease.

1 to 10 of 30Source ClinicalTrials.gov

See all 30 registered outcomes

Outcomes30

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Death or Neurodevelopmental Impairment	Birth to 22-26 months corrected age	The analysis population includes all randomized infants with available data for death and/or neurodevelopmental impairment.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Death	Birth to 22-26 months corrected age	The analysis population includes all randomized infants with available vital status.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Neurodevelopmental Impairment	at 22-26 months corrected age	The analysis population includes all randomized infants with available data for neurodevelopmental impairment.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Cognitive Delay	at 22-26 months corrected age	The analysis population includes all randomized infants with available data at the two-year followup.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Moderate or Severe Cerebral Palsy	at 22-26 months corrected age	The analysis population includes all randomized infants with available data at the two-year followup.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Severe Vision Impairment	at 22-26 months corrected age	The analysis population includes all randomized infants with available data at the two-year followup.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Severe Hearing Impairment	at 22-26 months corrected age	The analysis population includes all randomized infants with available data at the two-year followup.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Survival to Discharge Without Severe Complications	Birth to initial hospital discharge or to death if it occurs earlier (a median of 97 days)	The analysis population includes all randomized infants with available data up to hospital discharge or death.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Bronchopulmonary Dysplasia, Diagnosed on the Basis of the Need for Supplemental Oxygen After a Standardized Oxygen Reduction Test at 36 Weeks of Postmenstrual Age	at 36 weeks postmenstrual age	The analysis population includes all randomized infants with available data at 36 weeks postmenstrual age.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Retinopathy of Prematurity Stage >=3 or Treatment for That Condition Received	Birth to initial hospital discharge or to death if it occurs earlier (a median of 97 days)	The analysis population includes all randomized infants with available data up to hospital discharge or death.	Participants	COUNT_OF_PARTICIPANTS

1 to 10 of 30Source ClinicalTrials.gov

See all 30 outcomes

Results by group104

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Death or Neurodevelopmental Impairment	High Transfusion Threshold	Death or Neurodevelopmental Impairment	423	Participants
Death or Neurodevelopmental Impairment	Low Transfusion Threshold	Death or Neurodevelopmental Impairment	422	Participants
Death or Neurodevelopmental Impairment	High Transfusion Threshold	No Death nor Neurodevelopmental Impairment	422	Participants
Death or Neurodevelopmental Impairment	Low Transfusion Threshold	No Death nor Neurodevelopmental Impairment	425	Participants
Death	High Transfusion Threshold	Death	146	Participants
Death	Low Transfusion Threshold	Death	135	Participants
Death	High Transfusion Threshold	No Death	757	Participants
Death	Low Transfusion Threshold	No Death	766	Participants
Neurodevelopmental Impairment	High Transfusion Threshold	Neurodevelopmental Impairment	277	Participants
Neurodevelopmental Impairment	Low Transfusion Threshold	Neurodevelopmental Impairment	287	Participants

1 to 10 of 104Source ClinicalTrials.gov

See all 104 results by group

Participant flow14

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	High Tranfusion Threshold	911
Overall Study	STARTED	Low Transfusion Threshold	913
Overall Study	Completed Assessment for Neurodevelopmental Impairment	High Tranfusion Threshold	699
Overall Study	Completed Assessment for Neurodevelopmental Impairment	Low Transfusion Threshold	712
Overall Study	Died After Discharge	High Tranfusion Threshold	19
Overall Study	Died After Discharge	Low Transfusion Threshold	10
Overall Study	Died Before Discharge	High Tranfusion Threshold	127
Overall Study	Died Before Discharge	Low Transfusion Threshold	125
Overall Study	Survived to Discharge	High Tranfusion Threshold	781
Overall Study	Survived to Discharge	Low Transfusion Threshold	781

1 to 10 of 14Source ClinicalTrials.gov

See all 14 participant flow

Adverse events54

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Hyperkalemia -- non-hemolyzed specimen, up to 24 hours post-transfusion	Metabolism and nutrition disorders	High Tranfusion Threshold	58	908
other	Hyperkalemia -- non-hemolyzed specimen, up to 24 hours post-transfusion	Metabolism and nutrition disorders	Low Transfusion Threshold	40	906
other	Respiratory Deterioration up to 24 hours post-transfusion	Respiratory, thoracic and mediastinal disorders	High Tranfusion Threshold	147	908
other	Respiratory Deterioration up to 24 hours post-transfusion	Respiratory, thoracic and mediastinal disorders	Low Transfusion Threshold	146	906
serious	Hemolysis	Blood and lymphatic system disorders	High Tranfusion Threshold	1	908
serious	Hemolysis	Blood and lymphatic system disorders	Low Transfusion Threshold	0	906
serious	Adrenal Insufficiency	Endocrine disorders	High Tranfusion Threshold	2	908
serious	Adrenal Insufficiency	Endocrine disorders	Low Transfusion Threshold	0	906
serious	Ascites	Gastrointestinal disorders	High Tranfusion Threshold	1	908
serious	Ascites	Gastrointestinal disorders	Low Transfusion Threshold	0	906

1 to 10 of 54Source ClinicalTrials.gov

See all 54 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	High Tranfusion Threshold	146	903
Total, all-cause mortality	Low Transfusion Threshold	135	901
Total, other adverse events	High Tranfusion Threshold	184	908
Total, other adverse events	Low Transfusion Threshold	164	906
Total, serious adverse events	High Tranfusion Threshold	206	908
Total, serious adverse events	Low Transfusion Threshold	197	906

Source ClinicalTrials.gov

Papers4

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
33382931	DERIVED	PubMed
37733345	DERIVED	PubMed
38700862	DERIVED	PubMed
40375228	DERIVED	PubMed

Grants2

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years	Source
U01HL112748	Transfusion-Associated Brain Improvement (TABI) Trial: Data Coordinating Center	DAS, ABHIK	RESEARCH TRIANGLE INSTITUTE	NATIONAL HEART, LUNG, AND BLOOD INSTITUTE	2012 to 2016	NIH RePORTER
U01HL112776	Transfusion-Associated Brain Improvement (TABI) trial - CCC	KIRPALANI, HARESH; BELL, EDWARD F	CHILDREN'S HOSP OF PHILADELPHIA	NATIONAL HEART, LUNG, AND BLOOD INSTITUTE	2012 to 2016	NIH RePORTER

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
High Tranfusion Threshold vs Low Transfusion Threshold: deaths from any cause	Trial comparisons
High Tranfusion Threshold vs Low Transfusion Threshold: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01702805

GET https://conductscience.org/api/trials/v1/NCT01702805/registered?page=2

API reference For AI assistants