Breastfeeding Support and Promotion Program to Improve the Health of Premature Babies (PAP-LM)

NCT06653595 | Completed

• 1 other identifier: HCB/2021/0595
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 2

Brief Summary

This study evaluates the effectiveness of a breastfeeding support and promotion program to increase exclusive breastfeeding rates in the preterm group. The intervention is performed by an Advanced Practice Nurse and International Board Certified Breastfeeding Consultant (IBCLC), with high expertise in breastfeeding problems. It is a combination of face-to-face, home care and telephone attention to improve the adherence to breastfeeding. The intervention lasts 6 months.

Conditions

Prematurity; Extreme; Prematurity

Keywords

IBCLC; advance practice nurse; best practice; breastfeeding rates; breastfeeding outcomes; interventions

Outcome Measures

Primary Outcomes (1)

• BREASTFEEDING RATES

  Exclusive Breastfeeding or Parcial Breastfeeding

  15 days postpartum, at 3 months and at 6 months postpartum

Secondary Outcomes (5)

• PREMATURE GROWTH

  15 days postpartum, at 3 and 6 months postpartum

• PREMATURE HEIGHT

  15 days postpartum, at 3 and 6 months postpartum

• PREMATURE CRANIAL PERIMETER

  15 days postpartum, at 3 and 6 months postpartum

• PUNTUATION IN DEVELOPMENT WITH ASQ-3

  At 6 months postpartum

• MOTHER EFFICACY WITH BREASTFEEDING (USING BSES)

  15 days postpartum and at 6 months postpartum

Study Arms (2)

CONTROL GROUP

NO INTERVENTION

The Control Group receives the usual intervention from the health center, that consists in breastfeeding support in the NICU 1 time/week until hospital discharge.

EXPERIMENTAL GROUP

EXPERIMENTAL

The Experimental Group receives the PAP-LM programme.

Other: Programme to Support Breastfeeding

Interventions

Programme to Support Breastfeeding OTHER

The intervention consists of active support for breastfeeding by a lactation expert and IBCLC until the premature baby is 6 months old. The intervention includes: 1 face-to-face pre-discharge session, 8 home sessions up to 4 months and 3 telephone sessions up to 6 months.

EXPERIMENTAL GROUP

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Moderate premature
• Late premature babies
• Admitted to the NICU of Hospital Clínic
• Single pregnancy
• Families residing in the Barcelona Metropolitan Area (AMB)
• Families with a good mental health
• Families with a desire for Exclusive Breastfeeding up to 6 months

You may not qualify if:

• Maternal diseases that contraindicate breastfeeding
• Mothers with a history of breast surgery
• Mothers with a history of severe hypogalactia
• Premature babies with severe complications
• Premature babies diagnosed with severe CIR

Sponsors & Collaborators

• University of Barcelona: lead

Study Sites (2)

Rosselló 230

Barcelona, 08008, Spain

Location

C/Sabino de Arana, 1

Barcelona, 08028, Spain

Location

Related Publications (11)

• Bonuck KA, Trombley M, Freeman K, McKee D. Randomized, controlled trial of a prenatal and postnatal lactation consultant intervention on duration and intensity of breastfeeding up to 12 months. Pediatrics. 2005 Dec;116(6):1413-26. doi: 10.1542/peds.2005-0435.

  PMID: 16322166 BACKGROUND

• Bonuck K, Stuebe A, Barnett J, Labbok MH, Fletcher J, Bernstein PS. Effect of primary care intervention on breastfeeding duration and intensity. Am J Public Health. 2014 Feb;104 Suppl 1(Suppl 1):S119-27. doi: 10.2105/AJPH.2013.301360. Epub 2013 Dec 19.

  PMID: 24354834 BACKGROUND

• Dias de Oliveira L, Justo Giugliani ER, Cordova do Espirito Santo L, Meirelles Nunes L. Counselling sessions increased duration of exclusive breastfeeding: a randomized clinical trial with adolescent mothers and grandmothers. Nutr J. 2014 Jul 17;13:73. doi: 10.1186/1475-2891-13-73.

  PMID: 25033743 BACKGROUND

• Gross RS, Mendelsohn AL, Gross MB, Scheinmann R, Messito MJ. Randomized Controlled Trial of a Primary Care-Based Child Obesity Prevention Intervention on Infant Feeding Practices. J Pediatr. 2016 Jul;174:171-177.e2. doi: 10.1016/j.jpeds.2016.03.060. Epub 2016 Apr 21.

  PMID: 27113376 BACKGROUND

• Hopkinson J, Konefal Gallagher M. Assignment to a hospital-based breastfeeding clinic and exclusive breastfeeding among immigrant Hispanic mothers: a randomized, controlled trial. J Hum Lact. 2009 Aug;25(3):287-96. doi: 10.1177/0890334409335482. Epub 2009 May 12.

  PMID: 19436060 BACKGROUND

• Kools EJ, Thijs C, Kester AD, van den Brandt PA, de Vries H. A breast-feeding promotion and support program a randomized trial in The Netherlands. Prev Med. 2005 Jan;40(1):60-70. doi: 10.1016/j.ypmed.2004.05.013.

  PMID: 15530582 BACKGROUND

• Nabulsi M, Tamim H, Shamsedine L, Charafeddine L, Yehya N, Kabakian-Khasholian T, Masri S, Nasser F, Ayash S, Ghanem D. A multi-component intervention to support breastfeeding in Lebanon: A randomized clinical trial. PLoS One. 2019 Jun 14;14(6):e0218467. doi: 10.1371/journal.pone.0218467. eCollection 2019.

  PMID: 31199849 BACKGROUND

• O'Reilly SL, McNestry C, McGuinness D, Killeen SL, Mehegan J, Coughlan B, O'Brien EC, O'Brien D, Szafranska M, Brosnan M, Sheehy L, Murtagh R, O'Hagan L, Corbett M, Walsh M, Keogh R, Power P, Woodcock M, Phelan M, Carroll A, Murray S, Scallan C, Dunn E, McAuliffe FM. Multicomponent perinatal breastfeeding support in women with BMI >25: The Latch On multi-centre randomised trial. BJOG. 2024 Aug;131(9):1197-1206. doi: 10.1111/1471-0528.17782. Epub 2024 Feb 12.

  PMID: 38344894 BACKGROUND

• Petrova A, Ayers C, Stechna S, Gerling JA, Mehta R. Effectiveness of exclusive breastfeeding promotion in low-income mothers: a randomized controlled study. Breastfeed Med. 2009 Jun;4(2):63-9. doi: 10.1089/bfm.2008.0126.

  PMID: 19239405 BACKGROUND

• Tahir NM, Al-Sadat N. Does telephone lactation counselling improve breastfeeding practices? A randomised controlled trial. Int J Nurs Stud. 2013 Jan;50(1):16-25. doi: 10.1016/j.ijnurstu.2012.09.006. Epub 2012 Oct 17.

  PMID: 23084438 BACKGROUND

• You H, Lei A, Xiang J, Wang Y, Luo B, Hu J. Effects of breastfeeding education based on the self-efficacy theory on women with gestational diabetes mellitus: A CONSORT-compliant randomized controlled trial. Medicine (Baltimore). 2020 Apr;99(16):e19643. doi: 10.1097/MD.0000000000019643.

  PMID: 32311936 BACKGROUND

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• MIREIA PASCUAL

  HOSPITAL CLÍNIC I PROVINICIAL DE BARCELONA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: We will be use the random.org program to randomize families into two groups: experimental group (which will receive the intervention) and control group (which will receive usual care).The experimental group intervention will include: 1 pre-discharge face-to-face session, 8 home sessions until 4 months, and 3 telephone sessions until the baby is 6 months old. All sessions will be conducted by an Advanced Practice Nurse and IBCLC Expert in breastfeeding issues.

Study Record Dates

• First Submitted: June 5, 2024
• First Posted: October 22, 2024
• Study Start: October 13, 2021
• Primary Completion: February 15, 2024
• Study Completion: March 20, 2024
• Last Updated: October 22, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)