Evidence map›Paper›PMID 21262884›Full record

Trial reportPediatrics2011

Effects of recombinant human prolactin on breast milk composition.

Camille E Powe, Karen M Puopolo, David S Newburg, Bo Lönnerdal, Ceng Chen, Maureen Allen, Anne Merewood, Susan Worden, Corrine K Welt

Registry-linked trialAbstract readComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in Pediatrics, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00181649 (Recombinant Human Prolactin for Lactation Induction in Adoptive Mothers), which is not on this map. Cited by 16 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 2 pooled it
1.8field-weighted citation impact, top 15% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00181649 phase2withdrawnnot on this map

Recombinant Human Prolactin for Lactation Induction in Adoptive Mothers

TypeinterventionalSponsorMassachusetts General HospitalRan2006 to 2011Enrolled0ConditionsLactationArmsRecombinant human prolactin
3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 2 syntheses or guidelines pooled it, 39 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Article
  4. Article
  5. Review
  6. Article
  7. Article
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  9. Review
  10. Review
  11. Article
  12. Management of Hypopituitarism.Journal of clinical medicine · 2019
    Review
  13. Article
  14. Review
  15. Review
  16. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 7 institutions in 2 countries.

Camille E PoweHarvard Medical School, Harvard University, Boston, Massachusetts 02114, USA.
Karen M Puopolo
David S Newburg
Bo Lönnerdal
Ceng Chen
Maureen Allen
Anne Merewood
Susan Worden
Corrine K Welt
Brigham and Women's Hospital · USHarvard University · USBoston Children's Hospital · USBoston University · USMassachusetts General Hospital · USUnité de Nutrition Humaine · FRUniversity of California, Davis · US

Funding

ZD6416 Analgesic--Painful Distal Symmetrical PolyneuropaM01RR001066 · NCRR · MASSACHUSETTS GENERAL HOSPITAL · PI BROWN, EMERY N · 1985 to 2008
$37.4M
ROLE OF DIETARY CONSTITUENTS ON GENE EXPRESSION IN INTESTINAL EPITHELIUMP30DK040561 · NIDDK · MASSACHUSETTS GENERAL HOSPITAL · PI CHRISTOPHER P DUGGAN · 1994 to 2026
$31.6M
Phase 2 Trial of Recombinant Human Prolactin for Lactation InsufficiencyR01FD003014 · FDA · MASSACHUSETTS GENERAL HOSPITAL · PI WELT, CORRINE K · 2005 to 2007
$439k
FDA HHS FD-R-003014NCRR NIH HHS M01 RR001066NCRR NIH HHS M01-RR-01066NIDDK NIH HHS P30 DK040561
6 · The paper itself

Abstract

objectiveThe objective of this study was to determine the impact of recombinant human prolactin (r-hPRL) on the nutritional and immunologic composition of breast milk.

methodsWe conducted 2 trials of r-hPRL treatment. In the first study, mothers with documented prolactin deficiency were given r-hPRL every 12 hours in a 28-day, open-label trial. In the second study, mothers with lactation insufficiency that developed while they were pumping breast milk for their preterm infants were given r-hPRL daily in a 7-day, double-blind, placebo-controlled trial. Breast milk characteristics were compared before and during 7 days of treatment.

resultsAmong subjects treated with r-hPRL (N = 11), milk volumes (73 ± 36 to 146 ± 54 mL/day; P < .001) and milk lactose levels (155 ± 15 to 184 ± 8 mmol/L; P = .01) increased, whereas milk sodium levels decreased (12.1 ± 2.0 to 8.3 ± 0.5 mmol/L; P = .02). Milk calcium levels increased in subjects treated with r-hPRL twice daily (2.8 ± 0.6 to 5.0 ± 0.9 mmol/L; P = .03). Total neutral (1.5 ± 0.3 to 2.5 ± 0.4 g/L; P = .04) and acidic (33 ± 4 to 60 ± 6 mg/L; P = .02) oligosaccharide levels increased in r-hPRL-treated subjects, whereas total daily milk immunoglobulin A secretion was unchanged.

conclusionsr-hPRL treatment increased milk volume and induced changes in milk composition similar to those that occur during normal lactogenesis. r-hPRL also increased antimicrobially active oligosaccharide concentrations. These effects were achieved for women with both prolactin deficiency and lactation insufficiency.

Indexed as

Double-Blind MethodFemaleHumansInfant, NewbornLactation DisordersMilk, HumanPilot ProjectsPremature BirthProlactinRecombinant ProteinsProlactinRecombinant Proteins

Identifiers

PMID21262884
PMCPMC3387861
OpenAlexW2166403597

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.