Evidence map›Paper›PMID 20718766›Full record

Trial reportClinical endocrinology2010

Recombinant human prolactin for the treatment of lactation insufficiency.

Camille E Powe, Maureen Allen, Karen M Puopolo, Anne Merewood, Susan Worden, Lise C Johnson, Amy Fleischman, Corrine K Welt

Registry-linked trialOpen access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Clinical endocrinology, 2010. 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 22 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed, 2 pooled it
2.3field-weighted citation impact, top 12% 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

22 citing papers in PubMed, 2 syntheses or guidelines pooled it, 46 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Review
  5. Article
  6. Neuropsychological complications of hypoprolactinemia.Reviews in endocrine & metabolic disorders · 2024
    Review
  7. Review
  8. The molecular basis of hypoprolactinaemia.Reviews in endocrine & metabolic disorders · 2024
    Review
  9. Diagnosis of hypoprolactinemia.Reviews in endocrine & metabolic disorders · 2024
    Review
  10. Article
  11. A long-acting prolactin to combat lactation insufficiency.bioRxiv : the preprint server for biology · 2023
    Article
  12. Review
  13. Article
  14. Management of Hypopituitarism.Journal of clinical medicine · 2019
    Review
  15. Prolactin - a pleiotropic factor in health and disease.Nature reviews. Endocrinology · 2019
    Review
  16. Review
  17. Current and emerging treatment options for spinal muscular atrophy.Degenerative neurological and neuromuscular disease · 2015
    Review
  18. Article
  19. Review
  20. 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

8 authors at 4 institutions in 1 country.

Camille E PoweHarvard Medical School Reproductive Endocrine Unit, Brigham and Women's Hospital, Boston University Medical School, Boston, MA, USA.
Maureen Allen
Karen M Puopolo
Anne Merewood
Susan Worden
Lise C Johnson
Amy Fleischman
Corrine K Welt
Brigham and Women's Hospital · USHarvard University · USMassachusetts General Hospital · USBoston University · US

Funding

ZD6416 Analgesic--Painful Distal Symmetrical PolyneuropaM01RR001066 · NCRR · MASSACHUSETTS GENERAL HOSPITAL · PI HOGE, ELIZABETH A · 1985 to 2008
$37.4M
ROLE OF DIETARY CONSTITUENTS ON GENE EXPRESSION IN INTESTINAL EPITHELIUMP30DK040561 · NIDDK · MASSACHUSETTS GENERAL HOSPITAL · PI Alessio Fasano · 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

contextLactation insufficiency has many aetiologies including complete or relative prolactin deficiency. Exogenous prolactin may increase breast milk volume in this subset. We hypothesized that recombinant human prolactin (r-hPRL) would increase milk volume in mothers with prolactin deficiency and mothers of preterm infants with lactation insufficiency.

designStudy 1: R-hPRL was administered in an open-label trial to mothers with prolactin deficiency. Study 2: R-hPRL was administered in a randomized, double-blind, placebo-controlled trial to mothers with lactation insufficiency that developed while pumping breast milk for their preterm infants. PATIENTS: Study 1: Mothers with prolactin deficiency (n = 5). Study 2: Mothers of premature infants exclusively pumping breast milk (n = 11).

designStudy 1: R-hPRL (60 μg/kg) was administered subcutaneously every 12 h for 28 days. Study 2: Mothers of preterm infants were randomized to receive r-hPRL (60 μg/kg), placebo or r-hPRL alternating with placebo every 12 h for 7 days. MEASUREMENTS: Change in milk volume.

resultsStudy 1: Peak prolactin (27·9 ± 17·3 to 194·6 ± 19·5 μg/l; P < 0·003) and milk volume (3·4 ± 1·6 to 66·1 ± 8·3 ml/day; P < 0·001) increased with r-hPRL administration. Study 2: Peak prolactin increased in mothers treated with r-hPRL every 12 h (n = 3; 79·3 ± 55·4 to 271·3 ± 36·7 μg/l; P < 0·05) and daily (101·4 ± 61·5 vs 178·9 ± 45·9 μg/l; P < 0·04), but milk volume increased only in the group treated with r-hPRL every 12 h (53·5 ± 48·5 to 235·0 ± 135·7 ml/day; P < 0·02).

conclusionTwice daily r-hPRL increases milk volume in mothers with prolactin deficiency and in preterm mothers with lactation insufficiency.

Indexed as

AdultFemaleHumansInfant, NewbornInfant, PrematureLactation DisordersMilk, HumanPilot ProjectsProlactinRecombinant ProteinsProlactinRecombinant Proteins

Identifiers

PMID20718766
PMCPMC6488522
OpenAlexW2145603766

What OpenQuestion holds

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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.