Common Protocols
 [PHOTO: Edison Whitney, JHU/CCP] |
| Birth outcomes have improved significantly in the past 20 years, but there remains a wide gap between developing and developed countries. |
In addition to
For these studies, the Global Network Data Coordinating Center will work with research units to design qualitative studies, train research staff, and analyze resulting data. This will ensure interventions are tailored for each country but still amenable to cross-country comparisons. Such work will provide insight about country-specific conditions that might affect of data collection and intervention procedures. Global Network activities will be participatory, combining the expertise of specialists around the world, and helping to build local capacity for future work.
First Breath
Birth asphyxia (defined as “failure to initiate and sustain normal breathing at birth”) has been identified by the World Health Organization (WHO) as the most frequent cause of early death world wide, accounting for about 20 of neonatal mortality. Although prompt resuscitation after birth can prevent many of the deaths and reduce disabilities in survivors from birth asphyxia, the WHO has concluded that resuscitation is often not initiated or the methods used are inadequate or wrong. Neonatal resuscitation is a simple, inexpensive, readily available, and cost effective intervention. Even though the principles of the Neonatal Resuscitation Program (NRP) are recommended for international application; this program, widely used in the developed world, has had no dissemination in communities in many developing countries. The effects of standardized resuscitation training at the community level on neonatal outcome have not been tested in a randomized controlled trial. Training in neonatal resuscitation may be a simple, inexpensive, and cost-effective intervention that markedly improves neonatal outcome.
The Global Network will evaluate the effectiveness of the NRP training on neonatal mortality at 7 days. In order to establish reliable mortality rates, active baseline data collection will be occur at all participating Global Network communities. Following 6 months of baseline data collection period, training of all of the health care providers and birth attendants in the WHO Integrated Management of Pregnancy and Childbirth: Pregnancy, Postpartum, and Newborn Care Guide for Essential Practice (2003): Essential Newborn Care (ENC) course will be performed using a train-the-trainer system. After this training, an additional 6 months of baseline data collection will occur. Communities will then be randomized to either Early NRP (E-NRP) or Late NRP (L-NRP) training. After 12 months of data collection, the 7-day mortality rates at the E-NRP vs. L-NRP communities to assess whether NRP has significantly reduced infant mortality beyond the WHO ENC training alone.
Tobacco Use
Smoking is regarded as one of the few potentially preventable factors associated with low birth weight, very preterm birth and perinatal death (Kramer 1987). In smoking prevalence studies conducted in the 1990s, smoking among pregnant women in developed countries was reported to be between 20 and 33 (Tappin 1997; Dodds 1995; Cnattingus 1997; Stewart 1995; Campion 1994; Wieman 1994; Husten 1996). In the countries represented by the Research Units that are members of the NICHD Global Network for Women’s and Children’s Health Research (Global Network), little data is available on smoking prevalence and other tobacco product use among pregnant women (Global Network 2001). In an effort to determine the prevalence of tobacco use (smoking and smokeless tobacco) and to collect relevant data in support of a potential smoking prevention or cessation intervention, the Tobacco Use Subcommittee of the Global Network, in collaboration with the National Cancer Institute (NCI), is conducting a survey of knowledge, attitudes and behaviors regarding tobacco use among pregnant women in the countries represented by participating Research Units.
GN Scholars
The Global Network Scholar initiative is an innovative program, designed to build capacity within the network by training a promising host country national at each site to develop and implement a research protocol that is ancillary to the site protocol. This approach allows the Scholar to gain hands on experience in clinical/epidemiological research. Each Scholar is mentored by members of the Global Network (GN).
In June 2004, Scholars from eight of the ten GN sites participated in a three-day training to review research methodology, to refine their research proposals, and to begin collaboration with their mentors. Seven Scholars developed a final research protocol that has been reviewed and approved by the protocol review sub-committee and that has been granted IRB approval. With the guidance of their mentors, the scholars will begin implementation of their studies in May 2005 using the research infrastructure that has been created by the site’s parent grant. Scholars are responsible for overseeing data collection and for the management and analysis of their data. Each scholar will then formally present the findings of their study to the Global Network Steering Committee in June 2006.
A summary of the GN Scholars and their protocols follows:
| GN Site | Qualification of Scholar | Title of Protocol |
|---|---|---|
| Site 01 (Argentina/Uruguay) | M.D. (Ob-Gyn); M.P.H. (Epidemiology) | Maternal Mortality, Maternal Morbidity and Early Neonatal Mortality in Argentina |
| Site 02 (Democratic Republic of Congo) | M.D. (Pediatrician) | Kangaroo Mother Care: Feasibility, acceptability and cost in Kinshasa, Democratic Republic of Congo |
| Site 03 (Zambia) | M.D. (Pediatrician) | Stillbirths and Early Neonatal Mortality in Lusaka District Urban Health Centers |
| Site 05 (Brazil) | M.D. (Ob-Gyn) | Compliance Assessment of Vitamin C and E for a High-risk Obstetric Population Using Self-report, Pill Counts and Medication Electronic Monitoring System (MEMS Ô ) |
| Site 06 (Guatemala) | M.D. (Ob-Gyn); M.P.H. (epidemiology) | Exposure to Second Hand Tobacco Smoke Among Pregnant Women in Guatemala |
| Site 08 (India-Belguam) | M.D. (Ob-Gyn) | The Association between Parental Consanguinity and Birth Weight: A Prospective Cohort Study at four Primary Health Center Areas of Belgaum District, Karnataka, India |
| Site 09 (Pakistan) | PhD (Nursing); M.P.H. (Public Health Policy and Management); Diploma in Midwifery | Community - Based Screening for Postpartum Depression among Urban Women of Pakistan |
Maternal Newborn Health (MNH) Registry
The Maternal Newborn Health Registry is a prospective, population-based study of pregnancy outcomes in 7 sites in 6 developing countries (Argentina, Guatemala, India, Pakistan, Zambia and Kenya). All pregnant women will be registered and their outcomes tracked to 6 weeks post-delivery. The primary purpose of this prospective, population-based observational study is to quantify and understand the trends in pregnancy outcomes in defined low-resource geographic areas over time, in order to provide population-based statistics on stillbirths, neonatal and maternal mortality. In addition, the data from the registry will help investigators plann future studies for the Global Network. The study began in June 2008.
EmONC Study: Keep All Mothers and Babies Alive
The EmONC Study will evaluating the ability of a team, whose skills have been enhanced through various training programs, to explore the problems related to poor pregnancy outcomes and to improve a system to care for women; a great deal of flexibility is provided to the team to develop solutions which fit their local needs. The EmONC Study is a cluster-randomized trial being conducted in 7 sites in 6 developing countries (Argentina, Guatemala, India, Pakistan, Zambia and Kenya). Three primary training components in the intervention clusters are EmONC facility training to address the primary causes of maternal and perinatal mortality, community moblization training and Home-Based Life Saving Skills (HBLSS) training to assist birth attendants in the identification of and referral of complications during delivery. The study started in June 2008.
Complementary Feeding
Inadequate and inappropriate complementary feeding are major factors contributing to excess morbidity and mortality in young children. Prominent among nutrient inadequacies are those of iron and zinc. While huge campaigns are being mounted to fortify complementary foods and to distribute supplements, the effectiveness of these programs is generally uncertain and they do not reach millions of rural poor. By comparison, little support is being given to local food-based solutions. These not only require diversity of plant foods but appear to require the inclusion of meat to achieve zinc and iron requirements. Local supplies of meat are achievable but only with a concerted international and local effort. To justify this effort requires a multi-site efficacy study, the results of which, if positive, will leave no doubt that the effort required to provide sustainable local sources of meat for complementary feeds is worthwhile. The principal hypothesis to be tested is that daily intake of beef (1 oz/d for 6-12 mo and 1.5 oz/d for 12-18 mo) added to usual primarily plant-derived complementary feeds plus selected repetitive nutrition education messages results in greater linear growth velocity than does a micronutrient (including Zn and Fe) fortified equi-caloric cereal/legume supplement plus the same educational messages.
Participants from four sites in the Global Network which have stunting rates 20, i.e. Guatemala, Pakistan and Zambia will be randomized by clusters to receive either ½ oz lyophilized beef (equivalent to 1 oz cooked beef)/d or the equi-caloric micronutrient-fortified plant-based supplement (both increasing by 50 at age 1 year). Both groups will receive three repetitive messages delivered by study coordinators and through the local health system as part of integrated health care. These are: provide a thick puree/gruel; feed complementary foods at least three times per day; and maximize dietary diversity. These interventions will be preceded by messages to promote exclusive breast feeding until 6 months and to start complementary feeding promptly at that time as far as possible. The meat or fortified cereal supplement will be provided daily in a group setting for each cluster; the food intervention and messages will be delivered at home by the community coordinator or their assistant. Outcome measures, obtained by a separate group of local, trained assessment staff, include: longitudinal linear growth between 6-18 months (primary outcome); weight and head circumference; assessment of dietary variety and diversity at 6,9,12, and 18 months; indices of iron, zinc and Vitamin B12 status at 18 months; neurocognitive development at 18 months; and incidence of diarrhea and lower respiratory infections. A positive multi-country, multi-culture outcome of this trial will demonstrate the efficacy of a regular intake of meat commencing at age 6 months to achieve nutritionally complete complementary feeding and will provide a strong rationale for global efforts to enhance local supplies of meat and achieve acceptance of meats as complementary food.
Antenatal Corticosteroids (ACT)
Preterm birth is a major cause of neonatal mortality, currently responsible for 28 of the deaths overall. As the contribution of preterm birth to neonatal deaths is well above 50% (MacDorman et al., 2005) in middle and high income countries, it is expected that as low income countries improve their development, the relative importance of this cause will increase. One of the most powerful perinatal interventions to reduce neonatal mortality is the administration of antenatal corticosteroids to pregnant women at high risk of preterm birth. The primary objective of this multi-country two-arm, parallel cluster randomized controlled trial is to reduce neonatal mortality through increasing the rate of antenatal corticosteroids (ACT) administration to eligible women. In this trial, ACTs will be delivered to eligible women in community settings through the use of Celestone® Unijects. Neonatal mortality will be assessed at 28 days in low birth weight infants. Low birth weight will be used as a proxy measure for prematurity.
60,000 women and newborns in 80 distinct geographical clusters in Argentina, Guatemala, Kenya, India, Pakistan and Zambia will be enrolled over and 18-month period. 6000 pregnant women in the intervention cluster will receive corticosteroids and 6000 low birth weight infants will be followed for outcome assessment. The intervention consists of (1) Diffusing recommendations for antenatal corticosteroids use to healthcare providers; (2) Improving the identification of women at high risk of preterm birth by measuring uterine height with a color-coded tape to estimate gestational age in women with specific risk factors and unknown gestational age (3) Providing antenatal corticosteroids kits containing betamethasone filled Uniject devices and instructions for administration. Women at high risk of preterm birth will receive two Uniject injections each preloaded with 12 mg of betamethasone suspension. Control clusters will not receive a specific intervention for comparison. All participating mothers of low birth weight babies, regardless of randomization assigment, will be provided with guidance on the special care needed for their infants.
