NCT01681017

Brief Summary

The primary purpose of this pre-post evaluation is to test the impact on perinatal mortality (fresh stillbirths or early neonatal deaths) among births \> 1500g of training birth attendants at health facilities in the Helping Babies Breathe (HBB) and Essential Newborn Care (ENC) curricula. These facilities are located within clusters in the Global Network for Women's and Children's Health Research sites in Belgaum and Nagpur, India, and Eldoret, Kenya.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70,704

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2012

Typical duration for not_applicable

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

September 4, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 7, 2012

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

October 14, 2015

Status Verified

October 1, 2015

Enrollment Period

1.5 years

First QC Date

September 4, 2012

Last Update Submit

October 13, 2015

Conditions

Perinatal Mortality

Keywords

Perinatal MortalityAsphyxiaStillbirthNeonatal DeathResuscitationHelping Babies Breatheamong births greater than one thousand five hundred grams

Outcome Measures

Primary Outcomes (1)

  • Perinatal Mortality

    The difference in the rate of perinatal mortality (fresh stillbirth or neonatal death prior to 7 days) among births ≥1500g, pre versus post implementation of an integrated package of HBB and ENC training and equipment (referred to as HBB/ENC training and equipment). This measure will be calculated using delivery data from the Global Network's Maternal Newborn Health Registry for participating clusters.

    Perinatal mortality data collected at 6 weeks post-delivery. Comparison will include the pre-intervention period of 12 months and the post-intervention period of 12 months.

Secondary Outcomes (8)

  • Facility-based perinatal mortality

    Perinatal mortality data collected at 6 weeks post-delivery. Comparison will include the pre-intervention period of 12 months and the post-intervention period of 12 months.

  • Retention of resuscitation knowledge and skills

    Assessments completed at initial training and refresher training.

  • Number of neonatal resuscitations

    Resuscitation data collected at 6 weeks post-delivery.

  • Delivery room checklist score

    Observations conducted on a monthly basis.

  • Asphyxia related perinatal mortality

    Perinatal mortality data collected at 6 weeks post-delivery. Comparison will include the pre-intervention period of 12 months and the post-intervention period of 12 months.

  • +3 more secondary outcomes

Study Arms (4)

Facilities

OTHER

Have appropriate staff trained in HBB and have HBB equipment provided

Other: HBB/ENC supplies

Master Trainers

OTHER

Receive appropriate HBB training

Behavioral: HBB/ENC Training and Equipment

Facilitators

OTHER

Receive appropriate HBB training

Behavioral: HBB/ENC Training and Equipment

Learners

OTHER

Receive appropriate HBB training

Behavioral: HBB/ENC Training and Equipment

Interventions

HBB/ENC Training and EquipmentBEHAVIORAL

See the detailed description section

FacilitatorsLearnersMaster Trainers
HBB/ENC suppliesOTHER

Staffs associated with participating facilities receive HBB/ENC training and use related equipment.

Facilities

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Facilities:
  • at least 60 deliveries per year;
  • ability to provide 24-hour coverage, 7 days per week in the delivery ward; and
  • minimum perinatal mortality rate of 30 per 1000 deliveries in the reference period.
  • Master Trainers (MT)
  • Experienced teachers and content experts in neonatal resuscitation
  • Trained and/or experienced in education
  • Dedication to learner-focused education
  • Able to give informed consent
  • Facilitators
  • Experienced in teaching Learners in small groups
  • Experienced in care of newborns
  • Demonstrated understanding of course content
  • Aptitude for teaching
  • Able to give informed consent
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Jawaharlal Nehru Medical College

Belagavi, 590 010, India

Location

Lata Medical Research Foundation

Nagpur, 440013, India

Location

Moi University School of Medicine

Eldoret, 30100, Kenya

Location

Related Publications (4)

  • Patel A, Bang A, Kurhe K, Bhargav S, Prakash A, Arramraj S, Hibberd PL. Comparison of perinatal outcomes in facilities before and after Global Network's Helping Babies Breathe Implementation Study in Nagpur, India. BMC Pregnancy Childbirth. 2019 Sep 4;19(1):324. doi: 10.1186/s12884-019-2480-7.

    PMID: 31484498DERIVED

  • Bang A, Patel A, Bellad R, Gisore P, Goudar SS, Esamai F, Liechty EA, Meleth S, Goco N, Niermeyer S, Keenan W, Kamath-Rayne BD, Little GA, Clarke SB, Flanagan VA, Bucher S, Jain M, Mujawar N, Jain V, Rukunga J, Mahantshetti N, Dhaded S, Bhandankar M, McClure EM, Carlo WA, Wright LL, Hibberd PL. Helping Babies Breathe (HBB) training: What happens to knowledge and skills over time? BMC Pregnancy Childbirth. 2016 Nov 22;16(1):364. doi: 10.1186/s12884-016-1141-3.

    PMID: 27875999DERIVED

  • Bellad RM, Bang A, Carlo WA, McClure EM, Meleth S, Goco N, Goudar SS, Derman RJ, Hibberd PL, Patel A, Esamai F, Bucher S, Gisore P, Wright LL; HBB Study Group. A pre-post study of a multi-country scale up of resuscitation training of facility birth attendants: does Helping Babies Breathe training save lives? BMC Pregnancy Childbirth. 2016 Aug 15;16(1):222. doi: 10.1186/s12884-016-0997-6.

    PMID: 27527831DERIVED

  • Bang A, Bellad R, Gisore P, Hibberd P, Patel A, Goudar S, Esamai F, Goco N, Meleth S, Derman RJ, Liechty EA, McClure E, Carlo WA, Wright LL. Implementation and evaluation of the Helping Babies Breathe curriculum in three resource limited settings: does Helping Babies Breathe save lives? A study protocol. BMC Pregnancy Childbirth. 2014 Mar 26;14:116. doi: 10.1186/1471-2393-14-116.

    PMID: 24670013DERIVED

MeSH Terms

Conditions

Perinatal DeathAsphyxiaStillbirth

Interventions

Equipment and Supplies

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDeathPathologic ProcessesPathological Conditions, Signs and SymptomsWounds and InjuriesFetal Death

Study Officials

  • Linda L. Wright, MD

    Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 4, 2012

First Posted

September 7, 2012

Study Start

September 1, 2012

Primary Completion

March 1, 2014

Study Completion

December 1, 2014

Last Updated

October 14, 2015

Record last verified: 2015-10

Locations

KE(1)IN(2)