RECAP Preterm | PRIMAL - FU 24 months

Priming Immunity at the beginning of Life - Follow-up 24 months

Networks -

Variables -

Associated study

Acronym	PRIMAL
Name	Priming Immunity at the beginning of Life
Study design	Clinical trial
Number of very preterm (VPT) and/or very low birthweight (VLBW) births included in cohort (live & still births)	475
Number of term-born control births included in cohort (live & still births)	0
Countries	Germany

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Population

PRIMAL

Selection Criteria

Countries

Germany

Geographical Area

18 level 1 NICUs all over Germany

VPT/VLBW Group Inclusion Criteria

written informed consent of parents/caregivers and admission within 48 hours of life

Control Group Inclusion Criteria

Inclusion criteria were identical for the control and verum groups

VPT/VLBW Group Exclusion Criteria

Major malformations incompatible with survival beyond 48 hours or severely affecting the gastrointestinal tract (precluding adequate enteral feeding, requiring neonatal surgery, or associated with NEC Bell stage ≥1B)

Control Group Exclusion Criteria

Exclusion criteria were identical for the control and verum groups

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Data Collection Event

FU 24 months

Overview

Type of Data Collection Event: Follow-up
Start Date: 2018-04
End Date: 2020-06

Data sources

Others : Case report forms (CRFs); data collection via structured telephone interviews with parents

Participants

Age at Data Collection Event (years): 2
Corrected Age

	VPT/VLBW Group	Control Group
Survived	306	312
Invited	306	312
Assessed	225	239

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Collected Dataset / PRIMAL - FU 24 months

Priming Immunity at the beginning of Life - Follow-up 24 months

Associated study

Population

PRIMAL

Data Collection Event

FU 24 months

Files

Variables Classifications